EU Biosimilar Filings, Opinions And Approvals
A list of EU biosimilar filings, CHMP opinions and EU marketing authorizations, including details of the biosimilar company, the brand name/INN, indication(s), the reference product/company, and the date and type of event, is provided in the Pink Sheet's newest Performance Tracker.
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Australia will begin its coronavirus vaccination program with Comirnaty. The Oxford University/AstraZeneca vaccine is expected to be the next to receive approval.
Hungary is going its own way when it comes to coronavirus vaccines, but its decision to allow the emergency use of the Oxford University/AstraZeneca vaccine may be only a symbolic expression of the government’s growing impatience with the EU.
Valneva is scaling up manufacture of its coronavirus vaccine alongside the clinical development program, with a view to meeting its commitment to provide millions of doses for use in the UK and the EU.